MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Catalog Number 545050501

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address loosening of the tibial component at the cement to implant interface.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 8147618
• MDR Text Key: 129816399
• Report Number: 1818910-2018-77686
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 545050501
• Device Lot Number: 3546917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR